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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLCS TOTAL KNEE SYSTEM - PFC SIGMA RPF KNEE SYSTEM
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantDEPUY, INC.
P.O. BOX 988
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988
PMA NumberP830055
Supplement NumberS092
Date Received10/27/2005
Decision Date11/17/2005
Product Code NJL 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES IN QUALITY CONTROLS TO THE FEMORAL COMPONENTS OF THE ABOVE REFERENCED COMPONENTS. THESE MODIFICATIONS ADD A REQUIREMENT FOR LINE CLEARANCE AND A STEP FOR COLOR CODE STICKER VERIFICATION BY A SECOND OPERATOR TO MANUFACTURING PROCESS SPECIFICATION (MPS) - 1699. THE 2ND OPERATOR COLOR CODE STICKER VERIFICATION STEP IS ALSO BEING ADDED TO THE TRAVELERS FOR THE AFFECTED PRODUCT.
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